ACTIVELLE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ESTRADIOL AS HEMIHYDRATE; NORETHISTERONE AS ACETATE

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

G03AA05

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ESTRADIOL AS HEMIHYDRATE 1 MG; NORETHISTERONE AS ACETATE 0.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic group:

NORETHISTERONE AND ESTROGEN

Therapeutic area:

NORETHISTERONE AND ESTROGEN

Therapeutic indications:

Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of , or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The experience treating women older than 65 years is limited.

Authorization date:

2014-06-30

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
ACTIVELLE
®
FILM-COATED TABLETS
ACTIVE INGREDIENTS:
ESTRADIOL AS HEMIHYDRATE 1 MG
NORETHISTERONE ACETATE 0.5 MG
Inactive ingredients and allergens in this medicine: See section 2
under ‘Important information
about some of this medicine’s ingredients’, and section 6
‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them,
even if it seems to you that their condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Activelle is intended for:
•
Relief of symptoms that are due to a drop in the level of the hormome
estrogen in postmenopausal
women, when at least one year has passed since their last natural
period.
•
Prevention of osteoporosis (bone thinning) in menopausal women who are
at high risk of future
fractures and who cannot be treated with other medicines for this
condition.
There is only limited experience of treating women older than 65.
THERAPEUTIC GROUP: progestagens and estrogens. continuous, combined
therapy.
Activelle is a continuous combined hormone replacement therapy (HRT).
It contains two types of
female hormones, estrogen and progestagen.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
_ _
•
You are SENSITIVE (allergic) to the active ingredients or to any of
the other ingredients
in this medicine (listed in section 6 ‘Additional information’).
•
You have, have had, or suspect having BREAST CANCER.
•
You have, or have had CANCER WHICH IS SENSITIVE TO ESTROGENS, such as
cancer of
the womb lining (endometrium), or if you are suspected of having this
type of cancer.
•
You have UNEXPLAINED VAGINAL BLEEDING.
•
You have EXCESSIVE THICKENING O

Summary of Product characteristics

Activelle IL SPC JAN21-Notification
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1.
NAME OF THE MEDICINAL PRODUCT
Activelle
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate
0.5 mg.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White film-coated, round, biconvex tablets with a diameter of 6 mm.
The tablets are engraved with
NOVO 288 on one side and the Apis bull on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
women with more than 1 year
after menopause.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are intolerant of, or
contraindicated for, other medicinal products approved for the
prevention of osteoporosis.
The experience treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Activelle is a continuous combined HRT product intended for use in
women with an intact uterus.
One tablet should be taken orally once a day without interruption,
preferably at the same time every day.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for the
shortest duration (see also section 4.4) should be used.
A switch to a higher dose combination product could be indicated if
the response after 3 months is
insufficient for symptom relief.
In women with amenorrhoea and not taking HRT or women in transition
from another continuous combined
HRT product, treatment with Activelle may be started on any convenient
day. In women in transition from a
sequential HRT regimen, treatment should start right after their
withdrawal bleeding has ended.
If the patient has forgotten to take a tablet, the tablet should be
taken as soon as possible within the next
12 hours. If more than 12 hours have passed, the tablet should be
discarded. Forgetting a dose may increase
the likelih